EP3350337A4 - Procédé de fabrication d'une formulation immunothérapeutique comprenant une souche de listeria de recombinaison - Google Patents

Procédé de fabrication d'une formulation immunothérapeutique comprenant une souche de listeria de recombinaison Download PDF

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Publication number
EP3350337A4
EP3350337A4 EP16847136.5A EP16847136A EP3350337A4 EP 3350337 A4 EP3350337 A4 EP 3350337A4 EP 16847136 A EP16847136 A EP 16847136A EP 3350337 A4 EP3350337 A4 EP 3350337A4
Authority
EP
European Patent Office
Prior art keywords
manufacturing
listeria strain
recombinant listeria
immunotherapeutic formulation
immunotherapeutic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16847136.5A
Other languages
German (de)
English (en)
Other versions
EP3350337A1 (fr
Inventor
Anu Wallecha
Yvonne Paterson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Pennsylvania Penn
Ayala Pharmaceuticals Inc
Original Assignee
University of Pennsylvania Penn
Advaxis Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Pennsylvania Penn, Advaxis Inc filed Critical University of Pennsylvania Penn
Publication of EP3350337A1 publication Critical patent/EP3350337A1/fr
Publication of EP3350337A4 publication Critical patent/EP3350337A4/fr
Withdrawn legal-status Critical Current

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    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/74Vectors or expression systems specially adapted for prokaryotic hosts other than E. coli, e.g. Lactobacillus, Micromonospora
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0005Vertebrate antigens
    • A61K39/0011Cancer antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/01DNA viruses
    • C07K14/025Papovaviridae, e.g. papillomavirus, polyomavirus, SV40, BK virus, JC virus
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
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    • C12N1/00Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20Bacteria; Culture media therefor
    • CCHEMISTRY; METALLURGY
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    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
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    • C12P21/00Preparation of peptides or proteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/58Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A61K2039/585Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation wherein the target is cancer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6068Other bacterial proteins, e.g. OMP
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6075Viral proteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/80Vaccine for a specifically defined cancer
    • A61K2039/892Reproductive system [uterus, ovaries, cervix, testes]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C07ORGANIC CHEMISTRY
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    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/01Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/06Fusion polypeptide containing a localisation/targetting motif containing a lysosomal/endosomal localisation signal
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    • C07K2319/00Fusion polypeptide
    • C07K2319/55Fusion polypeptide containing a fusion with a toxin, e.g. diphteria toxin
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    • C12N2330/50Biochemical production, i.e. in a transformed host cell
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    • C12N2511/00Cells for large scale production
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    • C12N2710/00011Details
    • C12N2710/20011Papillomaviridae
    • C12N2710/20022New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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    • C12N2710/00011Details
    • C12N2710/20011Papillomaviridae
    • C12N2710/20034Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • C12N2710/20011Papillomaviridae
    • C12N2710/20041Use of virus, viral particle or viral elements as a vector
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    • C12N2740/16011Human Immunodeficiency Virus, HIV
    • C12N2740/16211Human Immunodeficiency Virus, HIV concerning HIV gagpol
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  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
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  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
EP16847136.5A 2015-09-15 2016-09-13 Procédé de fabrication d'une formulation immunothérapeutique comprenant une souche de listeria de recombinaison Withdrawn EP3350337A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562218884P 2015-09-15 2015-09-15
PCT/US2016/051525 WO2017048714A1 (fr) 2015-09-15 2016-09-13 Procédé de fabrication d'une formulation immunothérapeutique comprenant une souche de listeria de recombinaison

Publications (2)

Publication Number Publication Date
EP3350337A1 EP3350337A1 (fr) 2018-07-25
EP3350337A4 true EP3350337A4 (fr) 2019-04-03

Family

ID=58289799

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16847136.5A Withdrawn EP3350337A4 (fr) 2015-09-15 2016-09-13 Procédé de fabrication d'une formulation immunothérapeutique comprenant une souche de listeria de recombinaison

Country Status (6)

Country Link
US (1) US20180265879A1 (fr)
EP (1) EP3350337A4 (fr)
CA (1) CA2998857A1 (fr)
HK (1) HK1258860A1 (fr)
MA (1) MA42841A (fr)
WO (1) WO2017048714A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9012141B2 (en) 2000-03-27 2015-04-21 Advaxis, Inc. Compositions and methods comprising KLK3 of FOLH1 antigen
CN103687611A (zh) 2011-03-11 2014-03-26 阿德瓦希斯公司 基于李斯特菌属的佐剂
BR112014022662A2 (pt) 2012-03-12 2017-10-03 Advaxis Inc Inibição da função de célula supressora seguindo tratamento de vacina de listeria
EP3107566A4 (fr) 2014-02-18 2017-10-11 Advaxis, Inc. Immunothérapie multi-cibles dirigée contre un biomarqueur
MA39849A (fr) 2014-04-24 2017-03-01 Advaxis Inc Souches de listeria utilisées comme vaccin recombinant et procédé de production
MA41644A (fr) 2015-03-03 2018-01-09 Advaxis Inc Compositions à base de listeria comprenant un système d'expression de minigènes codant pour des peptides, et leurs procédés d'utilisation
WO2018102584A1 (fr) 2016-11-30 2018-06-07 Advaxis, Inc. Compositions immunogènes ciblant des mutations récurrentes du cancer et leurs procédés d'utilisation
CN111356760A (zh) * 2017-09-19 2020-06-30 阿德瓦希斯公司 细菌或李斯特菌菌株的冻干组合物和方法
JP2021516972A (ja) * 2018-03-09 2021-07-15 アドバクシス, インコーポレイテッド Listeria株の弱毒化および感染性を評価するための組成物および方法
WO2019210034A1 (fr) * 2018-04-27 2019-10-31 Advaxis, Inc. Compositions et procédés d'évaluation de la puissance d'agents immunothérapeutiques à base de listeria

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007061848A2 (fr) * 2005-11-17 2007-05-31 The Trustees Of The University Of Pennsylvania Procedes pour la production, la culture, et la conservation de vecteurs vaccinaux de listeria
WO2008130551A2 (fr) * 2007-04-16 2008-10-30 The Trustees Of The University Of Pennsylvania Souche de listeria exempte de résistance aux antibiotiques et procédé pour la construction et l'utilisation de celle-ci

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7820180B2 (en) * 2004-09-24 2010-10-26 The Trustees Of The University Of Pennsylvania Listeria-based and LLO-based vaccines
US8771702B2 (en) * 2001-03-26 2014-07-08 The Trustees Of The University Of Pennsylvania Non-hemolytic LLO fusion proteins and methods of utilizing same
US8906664B2 (en) * 2004-08-13 2014-12-09 The Trustees Of The University Of Pennsylvania Methods for constructing antibiotic resistance free vaccines

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007061848A2 (fr) * 2005-11-17 2007-05-31 The Trustees Of The University Of Pennsylvania Procedes pour la production, la culture, et la conservation de vecteurs vaccinaux de listeria
WO2008130551A2 (fr) * 2007-04-16 2008-10-30 The Trustees Of The University Of Pennsylvania Souche de listeria exempte de résistance aux antibiotiques et procédé pour la construction et l'utilisation de celle-ci

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
MACIAG P C ET AL: "The first clinical use of a live-attenuated Listeria monocytogenes vaccine: A Phase I safety study of Lm-LLO-E7 in patients with advanced carcinoma of the cervix", VACCINE, vol. 27, no. 30, 19 June 2009 (2009-06-19), ELSEVIER, AMSTERDAM, NL, pages 3975 - 3983, XP026153147, ISSN: 0264-410X, [retrieved on 20090503], DOI: 10.1016/J.VACCINE.2009.04.041 *
See also references of WO2017048714A1 *
ZACHARY BRENNAN: "Advaxis nabs SynCo Bio for manufacturing of its lead cancer immunotherapy", 25 February 2014 (2014-02-25), XP002788855, Retrieved from the Internet <URL:https://www.biopharma-reporter.com/Article/2014/02/25/Advaxis-nabs-SynCo-Bio-for-manufacturing-of-its-lead-immunotherapy> [retrieved on 20190212] *

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Publication number Publication date
HK1258860A1 (zh) 2019-11-22
CA2998857A1 (fr) 2017-03-23
US20180265879A1 (en) 2018-09-20
EP3350337A1 (fr) 2018-07-25
WO2017048714A1 (fr) 2017-03-23
MA42841A (fr) 2018-07-25

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